Glycemic Fluctuations in Newly Diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome Subjects

Pituitary Adenoma Clinical Trial

Official title:

Characteristics of Glycemic Fluctuations in Newly Diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574793
• Other study ID #: KY2015-152
• Status: Completed
• Phase: N/A
• First received: October 9, 2015
• Last updated: January 20, 2018
• Start date: December 1, 2014
• Est. completion date: January 7, 2018

Study information

• Verified date: December 2014
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Glucose fluctuations present not only in patients with diabetes mellitus but also in subjects with normal glucose tolerance or impaired glucose regulation. People with Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome are at risk of impaired glucose metabolism. Glycemic variability is poorly studied in the nondiabetic individuals. The aim of the study is to investigate the characteristics of glucose fluctuations in the newly diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome individuals.

Description:

Glucose fluctuations present not only in patients with diabetes mellitus but also in subjects with normal glucose tolerance or impaired glucose regulation. Compared with traditional monitoring methods, continuous glucose monitoring system(CGMS) techniques provides a much more detailed understanding of shifting blood glucose levels throughout the day.It is considered reliable to evaluate glucose variability not only in patients with diabetes but also in nondiabetic individuals.

People with Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome are at risk of impaired glucose metabolism and developing diabetes mellitus.Some researchers have shown that 15-30% Growth Hormone-Secreting Pituitary Adenoma are suffering from diabetes, 15-36% impaired glucose regulation. The rate of Cushing Syndrome individuals is 10-30% and 40-45% separately.

Glycemic variability is poorly studied in the nondiabetic individuals and has not been studied in the newly diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome individuals. In this study CGM was used to dynamically monitor patients being newly diagnosed with Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 7, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• •newly diagnosed GH-releasing pituitary adenoma

• •newly diagnosed Cushing Syndrome

Exclusion Criteria:

• •history of diabetes mellitus and being treated with drugs

• •being treated with drugs which affect glucose metabolism in the lately 3 months

• •with other hormones affecting glucose metabolism secreted abnormally by pituitary

• •serious comorbidity like malignant tumour, severe hepatosis or nephropathy, serious hypertension(blood pressure> 180/110mmhg)

• •pregnant or breastfeeding women

• •patients allergic to patches or metal

Related Conditions & MeSH terms

• Adenoma
• Cushing Syndrome
• Growth Hormone-Secreting Pituitary Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Device:
• continuous glucose monitoring
Patients newly diagnosed GH-releasing pituitary adenoma or Cushing Syndrome in our department will be monitored blood glucose by CGMS Gold.

Locations

Country	Name	City	State
China	Xiaolong Zhao	Jing'an	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous glucose profiles of mean data of 24-hour continuous glucose monitoring by the CGMS Gold	The monitoring results consisted of one curve and 5 parameters	3 days
Secondary	The mean amplitude of glycemic excursion of newly diagnosed GH adenoma patients	The mean amplitude of glycemic excursion of newly diagnosed GH adenoma patients during the 3 days monitored by CGMS Gold	3 days
Secondary	The mean amplitude of glycemic excursion of newly diagnosed Cushing Syndrome patients during the 3 days monitored by CGMS Gold	The mean amplitude of glycemic excursion of newly diagnosed Cushing Syndrome patients during the 3 days monitored by CGMS Gold	3 days
Secondary	The correlation of MAGE and IGF-1 in newly diagnosed GH adenoma patients	By compared with the outcomes after treated by SSAs or surgery we want to get weather there is a correlation between MAGE and IGF-1 in GH adenoma patients	6 months
Secondary	The correlation of MAGE and cortison in newly diagnosed Cushing Syndrome patients	By compared with the outcomes after treated by surgery we want to get weather there is a correlation between MAGE and cortison in Cushing Syndrome patients	6 months